PMA P030050S043
- Device
- Sculptra and Sculptra Aesthetic
- Applicant
- Q-Med AB
- Product code
- LMH
- Decision date
- 2023-06-14
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for revisions to the clinician labeling and patient labeling as a result of postmarket surveillance data.
Current openFDA PMA Record
- Device
- Sculptra and Sculptra Aesthetic
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S043
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2023-06-14
- Decision code
- APPR
- Date received
- 2023-05-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for revisions to the clinician labeling and patient labeling as a result of postmarket surveillance data.